Value of Negative 18FDG PET/CT in Milan Out, Up-to-seven in, HCC Transplant Candidates

NCT05276037 | Recruiting DMC

• 1 other identifier: B707201939900
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 6

Brief Summary

Hepatocellular carcinoma (HCC) is a rising public health concern with few curative options but liver transplantion (LT) in highly selected cases. LT could save many other HCC patients but organ shortage has lead to the necessity of selection of patients with the best survival chances, namely the Milan criteria. Hepatocellular carcinoma (HCC) is the fifth most common cancer, and the third cause of cancer related-death worldwide. HCC incidence is rising in Western countries including Belgium. There are more than 1,000 new HCC diagnoses in Belgium every year, but only 90 to 100 patients suffering from HCC are listed for liver transplantation (LT). In fact, the scarcity of organ donors has forced the development of strict criteria to limit LT to patients who are likely to have excellent outcomes. The universally accepted LT criteria for HCC are the Milan criteria (1 HCC nodule ≤5 cm or 3 nodules ≤3cm) that lead to a low rate of post-LT recurrence (\>80% of disease free recurrence at 5 years). The majority of patients suffering from HCC outside the Milan criteria at the time of diagnosis is not eligible for LT and is therefore limited to palliative care. It is however considered that some of these patients with HCC outside the Milan criteria may benefit from LT with an acceptable risk of recurrence and chances of long-term disease-free survival (DFS). This fact has led to the extension of LT criteria for HCC in some centres in different countries, as for example the University of California San Francisco (UCSF) criteria, the up-to-seven criteria or the Asan criteria. The Belgian Liver-Intestine Allocation Committee (Be-LIAC) is a section of the Belgian Transplantation Society (BTS) composed of the 6 LT Belgian centres in charge of coordinating deceased LT activity in Belgium with the help of Eurotransplant. Be-LIAC has already built a retrospective HCC database that was successfully used for several scientific studies allowing international presentations and publications. Based on this successful experience, Be-LIAC is keen to continue with this national collaboration to initiate a prospective clinical observational database to better study the results of LT in Belgium and to evaluate potential of extension of LT criteria in HCC patients. Inclusion in this database will not change patient management or the allocation process of the liver grafts in Belgium. This project is financed by a 4-year (2019-2022) grant of the Belgian "Fondation contre le cancer" / "Stichting tegen Kanker".

Conditions

Hepatocellular Carcinoma

Keywords

Liver transplantation; Milan criteria; Prognostic factor; PET CT; recurrence

Outcome Measures

Primary Outcomes (1)

• Survival

  Intention-to-treat (at LT waiting list registration) and post LT disease-free (DFS), recurrence-free (RFS) and overall survivals (OS)

  1,2, 5, and 10 years after LT

Secondary Outcomes (2)

• FDG PET-CT as a pronostic factor for HCC patients undergoing liver transplantation

  1,2, 5, and 10 years after LT

• FDG PET-CT value in Milan-in patients

  1,2, 5, and 10 years after LT

Study Arms (2)

Study group

Milan-out, up-to-7-in, PET negative (≤1.15) HCC patients

Other: Liver transplantation

Control group

Milan-in HCC patients

Other: Liver transplantation

Interventions

Liver transplantation OTHER

Both groups will receive the same advantages on the LT waiting list (SE points)

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients (\> 18 and \< 80 years) suffering from HCC and discussed for potential deceased or living related LT (including combined transplantation) during multidisciplinary oncology meetings in the 6 Belgian LT centres (either direct listing for LT on the Eurotransplant waiting list or potential listing after downstaging or recurrence after other treatment).

You may qualify if:

• HepatoCellular Carcinoma
• Liver transplant candidate after multidisciplinary disccuss

You may not qualify if:

• Patients \< 18y or \> 80yr old
• Patients considered contra-indicated (CI) for LT due to non-liver-related medical problems (age, other cancer, psychiatric disease, uncontrolled infection, no compliance, active alcohol abuse, cardiac CI, pulmonary CI, surgical CI, other medical CI);
• Patients contra-indicated for LT due to the HCC: extra-hepatic metastases (M+), lymphatic involvement (N+), macro-vascular invasion.

Sponsors & Collaborators

• University of Liege: lead
• University Hospital, Ghent: collaborator
• Free University of Brussels: collaborator
• University Hospital, Antwerp: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

Study Sites (6)

University Hospital, Antwerp

Antwerp, Belgium

RECRUITING

Free University of Brussels

Brussels, Belgium

RECRUITING

University Hospital, Ghent

Ghent, Belgium

RECRUITING

Catholic University of Louvain

Leuven, Belgium

RECRUITING

Leuven University hospital

Leuven, Belgium

RECRUITING

ULiège

Liège, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The HCC liver explant stored in the local biobank of the transplant center.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Central Study Contacts

Olivier Detry, MD PhD

CONTACT

003242844757; olivier.detry@chuliege.be

Céline Lambrecht

CONTACT

003243678323; celine.lambrecht@chuliege.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Surgical head of the liver transplantation program

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: January 1, 2019
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6)